This ISO 13485 QMS FAQ answers frequently asked questions about ReadySet, Confluence, document management and medical device compliance.
Getting started and access
Is the Confluence Free plan sufficient for a regulated QMS space?
Often not. For example, Confluence Cloud page restrictions and the Confluence audit log are not available on the Free plan, and those controls are commonly used to support controlled documentation governance.
I can view pages but cannot edit them. Is something broken?
Not necessarily. Editing depends on both your space permissions and any page-level edit restrictions. In regulated spaces, most SOPs may be intentionally read-only to most users.
Can external auditors view parts of ReadySet without a license?
There are a few patterns: controlled “guest/limited access,” temporary licensed access, exports (PDF/Word), or (rarely) carefully scoped anonymous/public access. Which pattern is acceptable depends on your security model and regulatory strategy. Confluence supports exports and (if enabled) anonymous access as mechanisms, but governance is your decision.
Navigation and “where do I find things?”
What is the difference between the “QMS Active Space” and the “QMS Records Space”?
In many ReadySet-style implementations, the “Active” area contains the validated SOPs (procedures), templates, and controlled references; the “Records” area stores completed forms/records as objective evidence. This separation supports audit clarity: “template vs executed record.”
What should I use the “Technical Documentation Record Space” for?
This area is typically organized per device and stores device lifecycle evidence such as the Design History File (DHF), Device Master Record (DMR), and the technical file.
How do I quickly find a specific SOP or form?
Use Confluence search and/or navigate via the page tree. ReadySet-style naming conventions (e.g., SOP-XXX-###, FOR-XXX-###, REF-XXX-###) are designed to make search reliable, even when page titles are long. Confluence is built to search and retrieve pages across spaces and hierarchies.
How do I know I’m looking at the latest approved version?
Use the document’s own “status/version” header section (as defined by your ReadySet template) and, when needed, Confluence page history to confirm version lineage. Confluence retains page history and can restore prior versions without deleting later versions.
Confluence apps and prerequisites
Why is “Table Filter and Charts” mandatory in our setup?
Because many ReadySet forms/registers behave like interactive spreadsheets (filters, calculations, multi-sheet tables, structured data entry). The app is designed to turn Confluence tables into interactive reports and spreadsheet-like experiences rather than static wiki tables.
Is the “Table Filter and Charts” app hard to use?
For most users, it feels similar to spreadsheet work (cells, columns, structured lists), though it is still embedded in Confluence and has its own UI patterns. The key is understanding whether you are editing a normal Confluence table vs a spreadsheet macro/table app element.
Why is an e-signature app recommended (or required)?
Many regulated workflows require trustworthy approvals and a defensible audit trail for records and sign-offs, especially when you treat electronic records/signatures as equivalent to paper. For example, 21 CFR Part 11 contains explicit expectations around audit trails and controls for electronic records and signatures, and EU GMP Annex 11 also discusses audit trails and electronic signatures in computerized systems contexts. Your Quality/Regulatory team determines whether these apply to your device/business and what level of control is required.
What e-signature apps work in Confluence?
Examples exist on the Atlassian Marketplace that embed electronic signing and signature verification inside Confluence pages (e.g., “eSign Electronic Signatures for Confluence”). Your selection should be based on your compliance needs, auditability, and IT security constraints.
Do we also need an approval/workflow app if we have e-signatures?
Often yes, because “signature capture” and “workflow control” are different needs. Workflow apps (for example Comala Document Control) help enforce review steps, approver roles, and periodic review windows; signature apps capture approval evidence. Many organizations use both.
Do we need to validate Confluence or monitor it for audit readiness?
Many regulated teams treat validation and ongoing integrity checks as part of maintaining a compliant system. Some Marketplace apps explicitly position themselves as evidence-gathering or integrity-check automation for Confluence Cloud validation activities (for example SoftComply’s Validation for Confluence). Whether and how you do this is part of your QMS governance.
Linking and instance identifiers
What happens if link conversion isn’t done?
Users click a link inside an SOP/form/reference and land on a “page not found” or they get redirected to the old source instance—either way, navigation and traceability degrade, and the QMS becomes hard to use reliably. This is a known pain point when page IDs or absolute links don’t survive an import unchanged.
How do I find our Cloud ID?
Atlassian provides a support procedure to retrieve a site’s Cloud ID and clarifies that Cloud ID is distinct from Organization ID. Your Confluence/Jira admins can retrieve it via Atlassian Administration.
Working with controlled documents (SOPs, references, templates)
What is a “Form template” vs a “Completed form/record”?
A template is the validated structure you copy/use to execute an activity; a completed form is the resulting record that demonstrates the activity happened and captures outcomes. ISO 13485-oriented record control emphasizes that records must remain identifiable, legible, and retrievable, with controlled retention and protection.
What is a “Reference” document?
References commonly include supporting controlled information (lists, policies, standards applicability lists, infrastructure listings, etc.). They are often controlled similarly to SOPs, including versioning and approvals, because they can drive operational decisions.
I accidentally edited a template—what now?
Immediately notify the document owner/QA, and use page history to understand what changed and revert if needed. Confluence keeps page version history and supports rollback/restore workflows.
How do I suggest an improvement to a SOP without directly editing it?
Use comments, inline comments, or your organization’s defined “change request” path (often a workflow-driven request). Confluence keeps page history, so controlled edits are traceable, but your QMS should define who is allowed to change controlled documents.
Approvals and signatures
Why do I have to re-sign after an edit?
In regulated document control, edits often invalidate prior approval because the approved content has changed. Many signing procedures therefore require re-approval/signature after changes so the approval is tied to the final content state. This aligns with the general emphasis on controlled changes, traceability, and auditability.
Can Confluence show who changed what and when?
Yes—Confluence page history records versions and supports comparison between versions. Administrators can also use the Confluence audit log for certain site-level events and changes.
How to create tasks and assign them?
You can use Confluence tasks and @mentions to assign action items on a page.
Working with tasks, @mentions, and assignments
CAPA (Corrective and Preventive Actions)
How do I create a new Corrective Action or Preventive Action?
Usually by creating a new CA/PA page from the provided template (“CA-# Title” / “PA-# Title” pattern) and then linking it from the register. Use whatever workflow/signature rules your ReadySet deployment enforces for CAPA documentation. (Based on your tutorial video structure and common workflow patterns.
Why does the CAPA page ask for status, aging/delays, and effectiveness check?
These fields help demonstrate that actions are tracked to completion and verified for effectiveness—core expectations in CAPA systems and commonly audited in regulated QMS processes.
How do I link a CAPA to risk management?
Link the CAPA to the impacted risk file or risk analysis page and record whether there is RMF impact (risk control measure changes, residual risk changes). Confluence linking plus controlled change history supports traceability when governed properly.
Risk management (FMEA, RMF, ISO 14971-related work products)
Why is risk analysis built as a spreadsheet in Confluence?
Because risk tools often require structured tabular data (hazards, causes, probabilities, severities, control measures, residual risk) and benefit from spreadsheet behaviors such as formulas and consistent column constraints—capabilities that table/spreadsheet apps provide inside Confluence.
Who should approve risk documents?
Your QMS defines the roles (e.g., risk owner, QA/RA), and workflow/signature tools can enforce that approvals occur before “release.” Workflow/approval apps are often used specifically to implement role-based approvals and periodic reviews.
Technical documentation and per-device structures
Can we reuse the same QMS SOPs for multiple devices?
Typically yes. QMS-level SOPs and templates are shared (active space), while device-specific evidence and records live under each device’s documentation structure. This separation supports both reusability and per-device traceability.
Security, permissions, and exports
Can I export a SOP or record to PDF/Word?
f you can view the page, you can typically export it (page-level export is governed by view permission). Confluence supports exporting pages/spaces to formats including PDF and Word.
Who should be allowed to export an entire QMS space?
Usually only a small controlled admin group. “Export space” permission can allow exporting the whole space (including comments and attachments and potentially content not viewable by the exporter), so it is commonly restricted in regulated environments.
Can we make part of the QMS publicly accessible?
Confluence supports anonymous/public access, but only if anonymous access is enabled at the site level by admins and then allowed on the specific space. This is generally used cautiously because it increases exposure risk.
Troubleshooting and “what do I do if…”
I need to understand who changed permissions or important settings—where do I look?
Ask a Confluence administrator to check the Confluence audit log. It’s intended to help admins review key changes/events (availability depends on plan).
I think a link in ReadySet is pointing to the old/source instance—what should I do?
Report it as a “link conversion” defect. In migrations, absolute links and non-preserved page IDs are common causes; teams often fix these via bulk link rewriting or conversion tooling after the import.
Who do I contact for help?
Direct end users to a single support channel (e.g., “QMS Support” or “QA Systems Admin”) and list what to include: page link, screenshot, what you expected, what happened, your browser. For admin/system issues, Confluence admins are typically required for permissions, audit logs, and app installation.
